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Trial record 19 of 560 for:    Recruiting, Not yet recruiting, Available Studies | Teaching

Teaching Parents Reiki for Their Adolescents Receiving Palliative Care

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ClinicalTrials.gov Identifier: NCT03896165
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Akron Children's Hospital
Information provided by (Responsible Party):
Ohio State University

Brief Summary:
The proposed study addresses National Institute of Nursing Research (NINR) priorities of advancing symptom science to "develop [and] test … novel, scalable symptom management interventions, including complementary health approaches (CHAs), in real-world clinical settings to improve health outcomes and quality of life" and the science of compassion to improve palliative and end-of-life care through "developing, testing, and implementing personalized, culturally congruent, and evidence-based palliative and hospice interventions that best address the needs of underserved, disadvantaged, and diverse populations across the care continuum." A long-term bonus of teaching parents to deliver Reiki is that Reiki is highly scalable and once learned, costs nothing to use, an important potential overall cost savings over other CHAs.

Condition or disease Intervention/treatment Phase
Palliative Care Chronic Disease Other: Reiki Not Applicable

Detailed Description:

Despite advances in the assessment and treatment of symptoms, including pain in adolescents receiving palliative care, parents still report that their children suffer. Advances in medical science and care have led to a growing number of children living with life-limiting chronic conditions. Out of 83 million children under the age of 19,16 an estimated 600,000 to 1,600,00017 are living with life-threatening/life-limiting conditions and over 180,000 are considered "medically fragile." These children require intense medical and nursing care in the home and often experience lengthy, recurrent hospital stays, accounting for about 26% of hospital days and 41% of hospital charges. Adolescents with life-threatening/life-limiting conditions, many of whom are developmentally delayed, experience many symptoms and have complex co-morbidities requiring medical management.

Many of these adolescents could benefit from complementary health approaches (CHAs) such as Reiki, a gentle light touch biofield energy therapy. Parents of adolescents receiving palliative care also experience high levels of stress. Previous studies have shown that empowering parents in the care of their chronically ill child help parents better cope with challenges. Some CHAs show promise for symptom management without side effects, such as sedation from additional medication, thereby permitting greater alertness and allowing more interaction with family and friends. Preliminary evidence from the PIs pilot study showed that professionally-delivered Reiki is feasible for children and adolescents receiving palliative care at home. The majority of parents said they wished they could learn Reiki so they might provide this relaxing therapy in the moment it was needed rather than waiting for the next professional session. One non-experimental program found that teaching parents Reiki was feasible and acceptable in the hospital. Parents who participated in two or more training sessions felt more confident providing Reiki. During informal interviews, parents said they felt good at being an active participant in their child's care and that their child experienced increased comfort, relaxation, and decreased pain.

Parents of disabled adolescents receiving palliative care often suffer from high caregiver burden and chronic stress leading to co-morbidities and decreased QoL. A cross-sectional survey conducted in Europe examined stress in 818 parents caring for a child with cerebral palsy. Results showed that 26% of mothers had very high stress. When the child had a communication or intellectual impairment or moderate-to-severe pain, parental stress was higher. One study examined psychological burden for 204 parents of children with serious chronic conditions. This study found that 75% of parents reported depression, and 67% had anxiety. The investigators are interested in exploring whether adding a skill (Reiki) aimed at decreasing symptoms in the adolescent will result in a decrease in symptoms and chronic stress for the parent.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Mixed methods quasi-experimental one group design
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Teaching Parents Reiki for Their Adolescents Receiving Palliative Care
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: Teaching Reiki
Parent-adolescent pairs will be in the study for a total of nine weeks from enrollment to the follow up visit. During Week 1, the parent will receive Reiki training, a poster with suggested hand positions and a commercially-available book about Reiki in the home. During Week 2 the parent will receive a Reiki booster session with a repeat of the training and may ask questions in the home. At the end of Week 4, measures will be repeated either in person or by phone. During Week 8, measures will be repeated, another hair sample obtained and the parent will participate in a qualitative interview. The qualitative interview will be administered in person by trained Ohio State University College of Nursing study staff as part of the interview session. Interviews will be audio recorded using a hand-held audio recording device. Audio recording is voluntary and participants can choose to not have their interview recorded and still be a part of the study.
Other: Reiki
Reiki is a complementary health approach where trained providers place their hands lightly on or just above a person, in discrete positions, with the goal of facilitating the person's own healing response. A Reiki practitioner will perform the initial teaching and instruct the parent how to perform a simple 15-minute Reiki session. Parents will complete a return demonstration using light touch with their adolescent. Parents will be asked to complete a minimum of 15 minutes of Reiki with their adolescent at least five days per week for the four-week intervention period.




Primary Outcome Measures :
  1. Satisfaction of parents learning Reiki in the home to use with their adolescent receiving palliative care. [ Time Frame: Four weeks ]
    Satisfaction will be examined by computing the proportion of approached subjects who enroll in the study, the proportion of subjects who complete Reiki training, and the proportion of enrolled subjects who complete data collection.


Secondary Outcome Measures :
  1. Rate of change in adolescents' and parents' stress response (as measured by hair sample). [ Time Frame: Week 0, week 9 ]
    Explore the adolescents' and parents' stress response. We will measure hair cortisol at the beginning and again at week 9.

  2. Rate of change in adolescents' and parents' stress response (as measured by saliva alpha amylase). [ Time Frame: Week 1, week 2, week 3, week 4 ]
    We will also measure saliva alpha amylase twice per week for 4 weeks.

  3. Change in adolescents' and parents' symptom profile as measured by Patient Reported Outcome Measurement Information System (PROMIS) symptom questionnaire. [ Time Frame: Week 0, Week 4, Week 9 ]
    Explore the adolescents' and parents' symptom profile (as measured by changes in physical function, anxiety, depression, fatigue, sleep, social roles, and pain level).

  4. Explore the parents confidence in delivering Reiki through audio-recorded interviews [ Time Frame: Week 9 ]
    Explore parents' confidence in delivering Reiki to their adolescent after completing Reiki training and practicing providing Reiki to their adolescent.

  5. Explore parents' confidence their ability to help their adolescent through audio-recorded interviews [ Time Frame: Week 9 ]
    Explore parents' confidence their ability to help their adolescent after completing Reiki training and practicing providing Reiki to their adolescent.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants will include adolescent-parent dyads. Dyads will be included if the
  • Adolescent: (1) is 10 to 19 years old, (2) is receiving palliative care at home, (3) understands English
  • Parent: (1) provides care for the adolescent most days of the week and (2) is able to read and write English at the 6th grade level.

Exclusion Criteria:

  • if (1) either the adolescent or the parent are taking or have taken corticosteroids within the last 30 days (affects the hair cortisol levels), or (2) either the adolescent or the parent has less than one inch of hair.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896165


Contacts
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Contact: Susan E Thrane, PhD, RN 614-292-5684 Thrane.2@osu.edu
Contact: Grace Njoroge, MS 614-688-2530 Njoroge.6@osu.edu

Locations
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United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308
Contact: Michelle Jacobs       mjacobs@akronchildrens.org   
Principal Investigator: Sarah Friebert, MD         
The Ohio State University College of Nursing Active, not recruiting
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Akron Children's Hospital
Investigators
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Principal Investigator: Susan E Thrane, PhD, RN Ohio State University

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Responsible Party: Ohio State University
ClinicalTrials.gov Identifier: NCT03896165     History of Changes
Other Study ID Numbers: 2018X0079
PCRC_Pilot_Grant_2018-02p ( Other Grant/Funding Number: NINR U2CNR014637 )
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ohio State University:
Complementary Health Approach
Parent
Adolescent
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes